Defining the Radiotherapy Dose and Volume Parameters Affecting Postoperative Complications in Esophageal Cancer Patients

NCT ID: NCT02323776

Last Updated: 2016-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to identify features of the cumulative dose-volume histogram (DVH) for patients treated with trimodality therapy in oesophageal cancer and correlate these with postoperative complications.

Detailed Description

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Intention to treat analysis in patients initially assigned to be treated with the trimodality protocol: neoadjuvant chemoradiotherapy followed by surgery.

The investigators will retrospectively evaluate several parameters of the treatment planning of patients treated with a preoperative regimen (CROSS regimen 41,4 Gy in 23 fractions or 50, 4 Gy in 28 fractions ):

* PTV volume1
* MLD, V30, V20, V15, V10, VS5 (Volume lung less dan 5 Gy)2 (lung toxicity)
* MHD, V20, V30, V403 (heart toxicity)
* Mean stomach dose, V50 stomach
* Mitochondrial DNA if available per patient Pre-existing cardiac,pulmonary comorbidity, smoking behavior, BMI, type of surgery and chemotherapy (especially taxanes) will be scored and take into account in a multivariate analysis. The investigators will collect these data and correlate the data with the presence of postoperative complications, time of onset of complications and duration of hospitalization. These latter data are already scored in a prospective manner at the Atrium Medical Center in Heerlen.

Conditions

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Esophageal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Trimodality protocol

neoadjuvant chemoradiotherapy followed by surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Oesophageal cancer patients
* initially treated with a preoperative dose of radiation in combination with chemotherapy and subsequently undergone surgical resection

Exclusion Criteria

* Patients who were treated with definitive chemoradiation or palliative radiotherapy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht Radiation Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Lambin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastro Clinic, The Netherlands

Locations

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MAASTRO clinic

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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14-28-03/09

Identifier Type: -

Identifier Source: org_study_id

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